University of Sussex
Biological Safety Committee
Proposal and Risk Assessment for Categorisation of a Procedure
Involving Work with Genetically Modified Microorganisms
Other than Viruses
Guidance of completing Risk Assessments on Genetically Modified Organisms can be
found at the HSE website http://www.hse.gov.uk/biosafety/gmo/information.htm
Title of Project:
Person
responsible:
Department:
Date of
Application
Location of work
(Building & Room
No.)
1
Section 1 Personnel
Briefly indicate your experience of working with microorganisms and genetically
manipulated organisms and any training you have received
Other workers on the
project [if known]
Qualifications
2
Experience/Training
Section 2 Project
Description of the project, including the methods to be used and the purpose of
the genetic modification
Will you cultivate on a large scale (e.g. 10 or more litres per culture)? Yes/No
Host organism
Vector system
Origins and intended function of the genetic material involved
3
Section 3 Risk Assessment
NB: This section should include the justifications for any assessments made and
sufficient detail to support them.
Level of risk may be estimated using the matrix given in Appendix 1
Section 3A: Risk to Human Health
Characteristics of the host and any hazards associated with it
Level of Risk:
Characteristics of the vector system and any hazards associated with it
Level of Risk:
Source and characteristics of the inserted gene product and any hazards arising
directly from its use (include an estimation of the level of expression and
biological activity of the recombinant gene product)
Level of Risk:
Hazards arising from the alteration of any existing pathogenic traits, if
applicable
Level of Risk:
Potential hazard of sequences within the GMM being transferred to related
micro-organisms
Level of Risk:
4
The overall likelihood that, in the event of exposure, the GMM could cause harm
to human health
Level of Risk:
Assign the provisional containment level:
1 2 3 4
(Circle as appropriate)
Section 3B: Assessment for Environmental Harm
What is the capacity of the GMM to survive, establish, disseminate with and/or
displace other organisms?
Level of risk:
What is its ability to cause harm to animals?
Level of risk:
What is its ability to cause harm to plants?
Level of risk:
5
What is its ability to cause harm to other organisms?
Level of risk:
What is the potential for transfer of genetic material between the GMM and
other organisms?
Level of risk:
Is there any hazard as a result of phenotypic or genetic instability?
Level of risk:
Section 3C Final Activity Class
Assign the final activity class:
1 2 3 4
(Circle as appropriate)
6
Section 4 Control Measures Monitoring, and Inactivation
Provide details of the control measures to be used to protect human health and
the environment and the means by which their use and effectiveness will be
monitored. This must include details of the inactivation procedures to be
employed for waste contaminated with GMMs , the expected degree of kill and
any appropriate validation procedures.
Section 5: Emergency Planning
Does your departmental safety plan provide adequate protection
and provision for emergency action in case of accidental release?
If no, give details of specific extra safety measures which will be
applied to the project.
7
Yes / No
Departmental Signatures
Signed: ..............................................
(Supervisor of work)
Date…………….
Signed: ..............................................
(Departmental Biological Safety Officer)
Date:....................
Signed: ..............................................
(Head of Department)
Date:....................
Laboratory inspected and approved to be operating at the containment level
required
Signed: ..............................................
(Departmental Biological Safety Officer)
Date:....................
Approval for the project
Signed: ..............................................
(Chair of the Biological Safety Committee)
8
Date:....................
Appendix 1: Matrix for estimation of level of risk
[Consequence x likelihood = risk of causing harm
Consequence
of Hazard
Severe
High
Likelihood of Hazard
Medium
Low
High
High
Medium
Medium
High
Medium
Medium/Low
Low
Medium/Low
Low
Low
Negligible
Effectively
Zero
Effectively
Zero
Effectively
Zero
9
Negligible
Effectively
Zero
Effectively
Zero
Effectively
Zero
Effectively
Zero